Nonprescription Drug Manufacturers Association submitted "industry protocol consensus" to FDA Oct. 13 for the study of pyrilamine maleate in premenstrual pain. Pyrilamine was listed as Category III in the Tentative Final Monograph on Orally Administered Menstrual Drugs after FDA concluded its efficacy for relief of premenstrual pain and mood changes was not proven. NDMA's new randomized, double-blind crossover study would test 30 mg pyrilamine maleate four times daily v. placebo in 72 women aged 18-45 for six months.
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